Sustiva

INDICATIONS

SUSTIVA® (efavirenz)
in combination with other antiretroviral agents is indicated for the treatment
of human immunodeficiency virus type 1 (HIV-1) infection in adults and in
pediatric patients at least 3 months old and weighing at least 3.5 kg.

DOSAGE AND ADMINISTRATION

Adults

The recommended dosage of
SUSTIVA (efavirenz) is 600 mg orally, once daily, in combination with a
protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors
(NRTIs). It is recommended that SUSTIVA be taken on an empty stomach,
preferably at bedtime. The increased efavirenz concentrations observed
following administration of SUSTIVA with food may lead to an increase in
frequency of adverse reactions [see CLINICAL PHARMACOLOGY]. Dosing at
bedtime may improve the tolerability of nervous system symptoms [see
WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and PATIENT INFORMATION]. SUSTIVA capsules or tablets should be swallowed
intact with liquid. For patients who cannot swallow capsules or tablets, the
capsule sprinkle method of administration is recommended.

Concomitant Antiretroviral
Therapy

Dosage Adjustment

If SUSTIVA is coadministered
with voriconazole, the voriconazole maintenance dose should be increased to 400
mg every 12 hours and the SUSTIVA dose should be decreased to 300 mg once daily
using the capsule formulation (one 200 mg and two 50 mg capsules or six
50 mg capsules). SUSTIVA tablets should not be broken. [See DRUG
INTERACTIONS , Table 5 and CLINICAL PHARMACOLOGY, Tables 7 and 8).]

If SUSTIVA is coadministered with rifampin to patients
weighing 50 kg or more, an increase in the dose of SUSTIVA to 800 mg once daily
is recommended [see DRUG INTERACTIONS, Table 5 and CLINICAL
PHARMACOLOGY, Table 8].

Pediatric Patients

It is recommended that SUSTIVA be taken on an empty
stomach, preferably at bedtime. Table 1 describes the recommended dose of
SUSTIVA for pediatric patients 3 months of age or older and weighing between
3.5 kg and 40 kg [see CLINICAL PHARMACOLOGY]. The recommended dosage of
SUSTIVA for pediatric patients weighing 40 kg or greater is 600 mg once daily.
For pediatric patients who cannot swallow capsules, the capsule contents can be
administered with a small amount of food or infant formula using the capsule
sprinkle method of administration.

Table 1: SUSTIVA Dosing in Pediatric Patients

Patient Body Weight

SUSTIVA Daily Dose

Number of Capsulesa or Tabletsb and Strength to Administer

3.5 kg to less than 5 kg

100 mg

two 50 mg capsules

5 kg to less than 7.5 kg

150 mg

three 50 mg capsules

7.5 kg to less than 15 kg

200 mg

one 200 mg capsule

15 kg to less than 20 kg

250 mg

one 200 mg + one 50 mg capsule

20 kg to less than 25 kg

300 mg

one 200 mg + two 50 mg capsules

25 kg to less than 32.5 kg

350 mg

one 200 mg + three 50 mg capsules

32.5 kg to less than 40 kg

400 mg

two 200 mg capsules

at least 40 kg

600 mg

one 600 mg tablet OR three 200 mg capsules

aCapsules can be administered intact or as sprinkles. bTablets must not be crushed.

Capsule Sprinkle Method Of Administration

For pediatric patients at least 3 months old and weighing
at least 3.5 kg and adults who cannot swallow capsules or tablets, the capsule
contents may be administered with a small amount (1 to 2 teaspoons) of food.
Use of infant formula for mixing should only be considered for those young
infants who cannot reliably consume solid foods. Patients and caregivers must
be instructed to open the capsule carefully to avoid spillage or dispersion of
the capsule contents into the air. The capsule should be held horizontally over
a small container and carefully twisted to open. For patients able to tolerate
solid foods, the entire capsule contents should be gently mixed with an
age-appropriate soft food, such as applesauce, grape jelly, or yogurt, in the
small container. For young infants receiving the capsule sprinkle-infant
formula mixture, the entire capsule contents should be gently mixed into 2
teaspoons (10 mL) of reconstituted room temperature infant formula in a
medicine cup by carefully stirring with a small spoon, and then drawing up the
mixture into a 10 mL oral dosing syringe for administration. After
administration of the SUSTIVA-food or -formula mixture, an additional small
amount (approximately 2 teaspoons) of food or formula must be added to the
empty mixing container, stirred to disperse any remaining SUSTIVA residue, and
administered to the patient. The SUSTIVA-food or -formula mixture should be
administered within 30 minutes of mixing. No additional food should be consumed
for 2 hours after administration of SUSTIVA.

Further patient instructions on the capsule sprinkle
method of administration are provided in the FDA-approved patient labeling (see
PATIENT INFORMATION and INSTRUCTIONS FOR USE).

HOW SUPPLIED

Dosage Forms And Strengths

Capsules

200 mg capsules are gold color, reverse printed with
“SUSTIVA” on the body and imprinted “200 mg” on the cap.

50 mg capsules are gold color and white, printed with
“SUSTIVA” on the gold color cap and reverse printed “50 mg” on the white body.